Chronic Inflammatory Demyelinating PolyneuropathyPhase 3NCT01824251
Phase III Clinical Trial of NPB-01maintenance Therapy in Patients With Chronic Inflammatory Demyelinating Polyneuropathy.
A Phase 3 study testing NPB-01 in people with Chronic Inflammatory Demyelinating Polyneuropathy, run by Nihon Pharmaceutical Co., Ltd at 1 site in Japan.
Trial summary
Patients diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy were confirmed based on the European Federation of Neurological Societies/ Peripheral. Nerve Society Guideline. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Chronic Inflammatory Demyelinating Polyneuropathy
- What is being tested?
- NPB-01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2013to Sep 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients with progressive or relapsing motor and sensory dysfunction of more than one limb resulting from neuropathy within 2 months prior to the date informed consent is obtained.
- 2. Patients who INCAT score between 2-9. (If the INCAT score is 1 in upper limb, the INCAT score of 2 must be exclusively from leg disability to qualify.)
- 3. Patients who need high-dose intravenous immunoglobulin therapy.
- 4. Patients who continued treatment for CIDP without addition or increase at 30 days before informed consent.
- 5. Patients with greater than or equal to twenty years old at informed consent.
Who cannot join
- 1. Patients with evidence of myelopathy or demyelination of central nerve
- 2. Patients with evidence of stroke, central nerve system trauma, or persistent neurological deficits due to peripheral neuropathy from other causes（diabetic neuropathy, IgM paraproteinaemia, uraemic neuropathy, toxic neuropathy, hereditary neuropathy）
- 3. Patients with evidence of neuropathy or alcoholic neuropathy or vitamin deficiency neuropathy due to myeloma, lymphoma, sarcoidosis, systemic lupus erythematosus, malignancy, vasculitis, Crow-Fukase syndrome, Sjögren syndrome.
- 4. Patients with multifocal motor neuropathy.
- 5. Patients treated with plasmapheresis at 3 months before informed consent.
- 6. Patients treated with rituximab at 6 months before informed consent.
Show all 18Show fewer
- 7. Patients treated with high-dose intravenous immunoglobulin（greater than or equal to 1g/kg） at 8 weeks before informed consent.
- 8. Patients treated with intravenous immunoglobulin at 3 weeks before informed consent.
- 9. Patients with history of shock or hypersensitivity for NPB-01.
- 10. Patients with IgA deficiency.
- 11. Patients with malignancy at informed consent.
- 12. Patients with impaired liver function.
- 13. Patients with impaired renal function.
- 14. Patients with cerebro- or cardiovascular disorders.
- 15. Patients with high risk of thromboembolism.
- 16. Patients with hemolytic/hemorrhagic anemia.
- 17. Patients with decreased cardiac function.
- 18. Patients with decreased platelet.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: NPB-01(Intravenous Immunoglobulin) Maintenance Therapy for Patients With Chronic Inflammatory Demyelinating Polyneuropathy.
Patients diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy were confirmed based on the European Federation of Neurological Societies/ Peripheral. Nerve Society Guideline. Patients who meet all inclusion criteria and do not conflict with the exclusion criteria will receive NPB-01 (intravenous immunoglobulin) 400mg/kg/day for five consecutive days. Subsequently, patients receive NPB-01 1g/kg every 3weeks and evaluate the Inflammatory Neuropathy Cause and Treatment（INCAT） score and INCAT sensory sumscore（ISS） et al.
As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse events by one year after the start of the study treatment.
- Being tested
- NPB-01
- Keywords
- IVIG in Chronic Inflammatory Demyelinating Polyneuropathy, Patients with Chronic Inflammatory Demyelinating Polyneuropathy
- Medical subject headings
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPB-01Drug
Also called Intravenous immunoglobulin
| Study group | Role | What they receive |
|---|---|---|
| NPB-01 | Experimental | Intravenous immunoglobulin Receives: Drug: NPB-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients with more than 1point improvement in the INCAT score relative to baseline at 28weeks.
Measured: 28weeks
proportion of patients with more than 1point exacerbation in the INCAT score relative to 28weeks at 52weeks.
Measured: 52weeks
Secondary outcomes (5)
INCAT score
Measured: 1,4,7,10,13,16,19,22,25,28,31,34,37,40,43,46,49,52weeks
ISS
Measured: 1,4,7,10,13,16,19,22,25,28,31,34,37,40,43,46,49,52weeks
maximum grip strength
Measured: 1,4,7,10,13,16,19,22,25,28,31,34,37,40,43,46,49,52weeks
Medical Research Council（MRC） sum score
Measured: 1,4,7,10,13,16,19,22,25,28,31,34,37,40,43,46,49,52weeks
the amplitude of the compound muscle action potential of the most severely affected motor nerve
Measured: 1,4,28,52weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Inflammatory Demyelinating PolyneuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nihon Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01824251
- Sponsor's protocol ID
- NPB-01-09/C-01
- Status last verified
- Oct 2014
- First submitted
- 1 Apr 2013
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Kuwabara S, Mori M, Misawa S, Suzuki M, Nishiyama K, Mutoh T, Doi S, Kokubun N, Kamijo M, Yoshikawa H, Abe K, Nishida Y, Okada K, Sekiguchi K, Sakamoto K, Kusunoki S, Sobue G, Kaji R; Glovenin-I CIDP Study Group. Intravenous immunoglobulin for maintenance treatment of chronic inflammatory demyelinating polyneuropathy: a multicentre, open-label, 52-week phase III trial. J Neurol Neurosurg Psychiatry. 2017 Oct;88(10):832-838. doi: 10.1136/jnnp-2017-316427. Epub 2017 Aug 2.
PubMed 28768822
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NPB-01(Intravenous Immunoglobulin) Maintenance Therapy for Patients With Chronic Inflammatory Demyelinating Polyneuropathy.
- ClinicalTrials.gov ID
- NCT01824251
- Acronym / sponsor ID
- NPB-01-09/C-01
- Keywords
- IVIG in Chronic Inflammatory Demyelinating Polyneuropathy, Patients with Chronic Inflammatory Demyelinating Polyneuropathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Nihon Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 4 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy were confirmed based on the European Federation of Neurological Societies/ Peripheral. Nerve Society Guideline. Patients who meet all inclusion criteria and do not conflict with the exclusion criteria will receive NPB-01 (intravenous immunoglobulin) 400mg/kg/day for five consecutive days. Subsequently, patients receive NPB-01 1g/kg every 3weeks and evaluate the Inflammatory Neuropathy Cause and Treatment（INCAT） score and INCAT sensory sumscore（ISS） et al.
As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse events by one year after the start of the study treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NPB-01 | Experimental | Drug: NPB-01Intravenous immunoglobulin |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Patients with progressive or relapsing motor and sensory dysfunction of more than one limb resulting from neuropathy within 2 months prior to the date informed consent is obtained.
- 2. Patients who INCAT score between 2-9. (If the INCAT score is 1 in upper limb, the INCAT score of 2 must be exclusively from leg disability to qualify.)
- 3. Patients who need high-dose intravenous immunoglobulin therapy.
- 4. Patients who continued treatment for CIDP without addition or increase at 30 days before informed consent.
- 5. Patients with greater than or equal to twenty years old at informed consent.
Key exclusion criteria (18 listed)
- 1. Patients with evidence of myelopathy or demyelination of central nerve
- 2. Patients with evidence of stroke, central nerve system trauma, or persistent neurological deficits due to peripheral neuropathy from other causes（diabetic neuropathy, IgM paraproteinaemia, uraemic neuropathy, toxic neuropathy, hereditary neuropathy）
- 3. Patients with evidence of neuropathy or alcoholic neuropathy or vitamin deficiency neuropathy due to myeloma, lymphoma, sarcoidosis, systemic lupus erythematosus, malignancy, vasculitis, Crow-Fukase syndrome, Sjögren syndrome.
- 4. Patients with multifocal motor neuropathy.
- 5. Patients treated with plasmapheresis at 3 months before informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NPB-01Also: Intravenous immunoglobulin | Drug | NPB-01 |
Primary outcome
proportion of patients with more than 1point improvement in the INCAT score relative to baseline at 28weeks.
Time frame: 28weeks
proportion of patients with more than 1point exacerbation in the INCAT score relative to 28weeks at 52weeks.
Time frame: 52weeks
5 secondary outcomes
INCAT score
Time frame: 1,4,7,10,13,16,19,22,25,28,31,34,37,40,43,46,49,52weeks
ISS
Time frame: 1,4,7,10,13,16,19,22,25,28,31,34,37,40,43,46,49,52weeks
maximum grip strength
Time frame: 1,4,7,10,13,16,19,22,25,28,31,34,37,40,43,46,49,52weeks
Medical Research Council（MRC） sum score
Time frame: 1,4,7,10,13,16,19,22,25,28,31,34,37,40,43,46,49,52weeks
the amplitude of the compound muscle action potential of the most severely affected motor nerve
Time frame: 1,4,28,52weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
- Derived from this study: PubMed 28768822Kuwabara S, Mori M, Misawa S, Suzuki M, Nishiyama K, Mutoh T, Doi S, Kokubun N, Kamijo M, Yoshikawa H, Abe K, Nishida Y, Okada K, Sekiguchi K, Sakamoto K, Kusunoki S, Sobue G, Kaji R; Glovenin-I CIDP Study Group. Intravenous immunoglobulin for maintenance treatment of chronic inflammatory demyelinating polyneuropathy: a multicentre, open-label, 52-week phase III trial. J Neurol Neurosurg Psychiatry. 2017 Oct;88(10):832-838. doi: 10.1136/jnnp-2017-316427. Epub 2017 Aug 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NPB-01 in people with Chronic Inflammatory Demyelinating Polyneuropathy, run by Nihon Pharmaceutical Co., Ltd at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of patients with more than 1point improvement in the INCAT score relative to baseline at 28weeks. (time frame: 28weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01824251, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2016.